More puzzling questions about Sugen’s Sunitinib patent

Image from here

Going through Sugen’s Sunitinib patent file, once again, I came across a few more irregularities. I’ve blogged about the previous irregularities over here and here.

Normally, post 2005, after a patent application is filed before the India patent office it is published in the patent office journal after which any person can file a pre-grant opposition under Section 25(1) until such time that the patent was granted. After the publication, the patent is referred to an Examiner by a Controller. The Examiner is supposed to examine the patent application for anticipation and obviousness and submit his report to the Controller who will then conduct a hearing with the applicant and decide to grant or reject the patent. If the patent is granted, it is effective from the date it is published under Section 43(2) in the patent office journal.

Here’s the timeline on which the Sunitinib patent proceeded:

Most of the above events can be confirmed by reading the correspondence file available over hereand here.

(i) 9^th August, 2002: The patent application was filed and sent to the mailbox, to be opened on 1^stJanuary, 2005 when India became TRIPs compliant;

(ii) 7^th September, 2005: Sugen files a Form 18 requesting for examination of the patent application;

(iii) 17^th May, 2006: An examiner of the patent office sent Sugen’s patent agent a First Examination Report (FER);

(iv) 1^st June, 2006: Sugen replies to the FER;

(v) 16^th June, 2006: Examiner of the patent office who issued the FER, makes a file noting that he has discussed the file with the patent agent for Sugen and that the matter can proceed to grant. On the same day, the patent examiner sent Sugen a letter informing them that its patent had been granted subject to “completion of statutory time limit as mentioned under Section 25(1)”.  (I’ll get back to this later in the post)

(v) 16^th June, 2006: On this very same day on which the Examiner decided to grant the patent, Sugen’s patent agent makes a request in Form 9 to the Patent Office seeking publication of its patent under Section 11A.

(vi) 19^th January, 2007: The patent office publishes Sugen’s patent application under Section 11(A);

(vii) 1^st August, 2007: On this day, Sugen’s patent agent writes to the Patent Office seeking grant of the ‘Letters Patent Document’ and states (a) that the patent had already been granted by the patent office; (b) that it had been published by the patent office; (c) that no opposition had been received till date.

(viii) 5^th October, 2007: On this day, the grant of Sugen’s patent was published under Section 43(2) of the Patent Act and Sugen was now entitled to enforce its patent.

What are the glaring violations of the Patents Act in the above process?

(i) Examination before publication under Section 11A – no opportunity for a pre-grant opposition: The publication under Section 11A happened after the patent was granted instead of happening before the examination of the patent application. Rule 24B of the Patent Rules, 2005 clearly states that “A request for examination under Section 11B shall be made in Form 18 after the publication of the application”. Why was this procedure not followed by the Patent Office? Why did Patent Office begin with the examination process before publishing the patent application? The practical effect of concluding the examination process before the publication of the patent was to rob generic competitors with a right to file a pre-grant opposition to the patent in question. In 2007 generic pharmaceutical companies were filing pre-grant oppositions regularly but given the manner in which the patent office granted the patent and then published the application, most companies appear to have been robbed of an opportunity to file a pre-grant opposition.

(ii) Examiners do not have the power to conduct Section 15 hearings: Prior to Kurian’s tenure as the Controller General, the patent office used to basically follow its own version of the Patent Act and this is exactly what happened in this case. If you read the Patents Act from Sections 11 to 15 it is quite clear that Parliament envisaged a two-tiered screening of all patent applications i.e. the patent application goes to a Controller who assigns its to an examiner who is required under statute to examined the patent application for anticipation and obviousness, prepare a report and forward it to the Controller. The Controller then communicates to the patent applicant the gist of the Examiner’s report and grant the patent applicant a hearing if required. After that the Controller may accept or reject the patent application in question.

This is not what happened in the Sunitinib case. As is obvious from the file-noting on page 1 of the correspondence file, the Examiner has conducted the hearing himself and issued the letter of grant by himself. There has been no involvement of a second officer from the Patent Office. Like I’ve discussed earlier, this alone is a ground to have a writ court set aside a patent.

(iii) Did Sugen even know that the Patent Act, 1970 was amended?

What really surprised me while going through this file, was this line from Sugen’s letter to the Patent Office (page 16 of the correspondence file)

“This application was accepted by the respective Examiners/Controllers way back in June 2006 and we also received a letter of intimation of grant.

The above application has been published in the Patent Journal on 19.01.2007 and no opposition has been received till now.

There are many infringers in this market and we would like to pursue the infringers. However, we are unable to take any action since the final LPD document has not been issued to us.

We earnestly request this Office to kindly expedite the matter and issue LPD document as soon as possible” (sic)   

I am not sure about this, and am open to correction but doesn’t the above procedure as outlined by Sugen in its letter, dated 1^st August, 2007 actually refer to the procedure followed in India before the Patent Act was amended in 2005. The procedure before 2005 was that the patent application was examined by the Patent Office and was published in the patent office journal only after the patent application was accepted by the Patent Office. After its publication or ‘advertisement’ as it was then called, a ‘person interested’ had up to 4 months to file an opposition. If there was no opposition the patent was sealed and the patentee could then enforce his patent.

The above procedure changed completely in 2005 when Parliament amended India’s patent legislation. The process described by Sugen in its letter dated 1^st August, 2007 dates back to pre-2005. What was Sugen thinking?  

Conclusion: Given the sheer number of violations of the provisions of the Patent Act, 1970 there is no doubt that if the patent was not already revoked, any High Court in the country would have set aside the grant of the patent on the grounds that it did not conform to the scheme of the statute.

Once again, I ask – what was Sugen thinking?